Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

NCT03560167 | Completed FDA Device

• 1 other identifier: 5018
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 19

Brief Summary

This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

Conditions

Heart Failure; Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (1)

• Safety measured by device-related or procedure-related major adverse events (MAEs)

  Device-related or procedure-related major adverse events (MAEs)

  30-day

Study Arms (1)

AccuCinch® Ventricular Restoration System

EXPERIMENTAL

Device: AccuCinch® Ventricular Restoration System

Interventions

AccuCinch® Ventricular Restoration System DEVICE

AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

AccuCinch® Ventricular Restoration System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study patient is at least 18-years old
• Severity of FMR: ≥ Moderate (i.e., ≥2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2)
• Patient has had a prior surgical or percutaneous mitral repair procedure \>3 months prior to enrollment
• LV Ejection Fraction: ≥20 to ≤40%
• Symptom Status: NYHA II-IV (i.e., ambulatory)
• Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall include CRT and/or ICD when indicated by guidelines.
• Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

You may not qualify if:

• Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)
• Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
• Prior surgical, transcatheter, or percutaneous mitral valve replacement
• Untreated clinically significant coronary artery disease (CAD) requiring revascularization
• Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
• Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
• NYHA class IV (i.e., non-ambulatory)
• Fixed pulmonary artery systolic pressure \>70 mmHg
• Severe tricuspid regurgitation
• History of stroke within the prior 3 months or any prior stroke with Modified Rankin Scale ≥ 4 disability
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
• Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system)
• Renal insufficiency (i.e., eGFR of \<30ml/min/1.73m2; Stage 4 or 5 CKD)
• Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
• Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

Study Sites (19)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Piedmont Heart

Atlanta, Georgia, 30309, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Minneapolis Heart Foundation Institute

Minneapolis, Minnesota, 55407, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

PinnacleHealth Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, 77020, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84109, United States

Location

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

Virginia Tech Carilion School of Medicine and Research Institute

Roanoke, Virginia, 24014, United States

Location

University of Washington Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Zapien, MS, CCRA

  Ancora Heart, Inc.

  STUDY DIRECTOR

• Kendra Grubb, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Guilherme Silva, MD

  Baylor St. Luke's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: September 24, 2018
• Primary Completion: March 25, 2021
• Study Completion: January 28, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

US (19)